Description
SRG Clinical is currently assisting in the recruitment of Clinical Project Leader who is driven by research and a passion for science our client is a Pharmaceuticals company dedicated to the development of innovative treatments that make a real difference in people's lives all over the world.
THE JOB
You will be accountable for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed timelines. Your essential tasks will be to:
Collaborate with relevant stakeholders for preparation of Clinical Development Plans to facilitate timely identification of planned clinical trial activities and to provide operational input.
Ensure planning, execution and finalisation of clinical trial activities according to agreed strategy, timelines and budget. In case of deviations from plan, ensure decision on what to do
Ensure appropriate compliance with GCP, SOPs, guidelines and regulatory requirements
Collaborate across clinical operations teams globally for the assigned clinical project to ensure alignment with agreed strategy, project standards and knowledge-sharing between clinical trials within a project.
Ensure development and management of trial budget and assignment of internal resources and ensure regular updates of external costs and resources in PLW.
Interact, build and maintain relationships with key internal functions and external stakeholders such as e.g. regulatory agencies, experts and key opinion leaders
Approve operational plan, Sponsor Oversight Plan, Centralised Monitoring Plan, CRO selection and IA.
Ensure oversight of vendors for projects/ trials to meet objectives for timelines, costs and quality.
Maintain contact with CRO oversight manager and serve as first point of escalation for Clinical Team in case of CRO performance issues.
QUALIFICATIONS
We expect you to have a Master degree within life sciences, extensive experience within clinical drug development and preferably at least 5 years' experience in managing clinical trials (phase I or phase II/III, as applicable) as a senior trial manager. You have GCP certification and experience with multi-country and multi-centre studies.
The successful candidate is bright, ambitious with an easy yet assertive personality. We expect you to be a true team player, able to navigate in a complex environment and to work independently and with authority.
You will need to be detail oriented with high quality standards. In addition, it is essential that you are well organized, pro-active and flexible with the ability to work on multiple tasks in a multicultural environment.
Excellent knowledge of MS Office and fluency in English with good verbal and written communication skills is a given
For more information please apply within!!
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.
